Cleared Traditional

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)

K891385 · Vitek Systems, Inc. · Chemistry
Apr 1989
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K891385 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS), a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 18, 1989, 40 days after receiving the submission on March 9, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K891385 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1989
Decision Date April 18, 1989
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DEW — Igg, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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